FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests
Congress Suspends Medical Device Tax for Two Years
When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices
FDA Releases Draft Guidance Documents on New Expedited Access Program for Premarket Approval of Medical Devices and Premarket and Postmarket Data Collection
FDA Seeks Enhanced Cybersecurity Risk Management Efforts, Including Premarket Submission Requirements, for Medical Device Manufacturers and Hospitals
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